US stops trial of "intermittent" AIDS treatment

WASHINGTON (Reuters) - The U.S. government stopped a trial of AIDS drugs on Wednesday aimed at finding out whether patients could take breaks from treatment, saying people were much more likely to become ill or die if they took breaks.

The trial quickly showed that patients do better when they continuously take the drugs, said the National Institute of Allergy and Infectious Diseases.

Some smaller studies had suggested that patients could safely take carefully monitored breaks from the strict regimens of drug cocktails that keep AIDS at bay.

But the larger, international trial showed that patients had twice the risk of dying or developing clinical AIDS if they took breaks from the drug cocktails, called highly active antiretroviral therapy or HAART.

"Furthermore, there was an increase in major complications such as cardiovascular, kidney and liver diseases in the participants on the drug conservation arm," the NIAID said in a statement. "These complications have been associated with (HAART), and it was hoped that they would be seen less frequently in those patients receiving less drug," it added.

The drug cocktails also cause nausea, diarrhea and other discomforts, and patients can build up resistance to the drugs, meaning the virus evolves and the drugs work less effectively over time.

The hope was the breaks would minimize these effects.

"We were surprised to learn that in the short term, episodic antiretroviral therapy carries such an increased risk without evidence of sparing patients the known side effects associated with ART (antiretroviral therapy)," said Dr. Wafaa El-Sadr of the Harlem Hospital Center and Columbia University in New York, who was working on the trial.

During the study, known as Strategies for Management of Anti-Retroviral Therapy, or SMART, patients either continuously took their drug treatments, or started only when numbers of key immune cells, called CD4 T-cells, dropped below a certain level.

When the trial was stopped, it was running in 33 countries with more than 5,000 patents taking part.